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Provides critical support to Medical Affairs, specifically with the Investigator Initiated Studies (IIS) Program, tracking of Non-Disclosure Agreements (NDAs) and granted study agreements, as well as managing the tracking and shipping of medical devices.
Responsibilities
Key Accountabilities
* Maintain accurate records of all NDAs and research agreements
* Monitor the status of research agreements and ensure timely execution
* Manage the inventory of medical devices used in Investigator Initiated Studies, including coordination of shipments and returns of loaned devices to and from research sites
* Maintain appropriate records to support successful reporting for loaned / free-of-charge materials; attend audits of compliance records as needed
* Support the clinical affairs team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to scope of work and SOPs
* Coordinate and communicate with investigators, legal, and compliance teams to address issues or delays
* Work with logistics and supply chain teams to resolve shipping issues
* Perform other duties as assigned
Networking/Key relationships
* Medical Affairs
* Operations (Logistics)
* Legal and Compliance
* External Stakeholders (Investigators, clinical study participants, etc.)
Qualifications
Minimum Knowledge & Experience:
* High School Diploma or equivalent required
* At least 3 years of administrative support experience
Management may substitute relevant work experience for a degree or adjust experience requirements.
Skills & Capabilities:
* Proficient in Microsoft Word, Excel, and PowerPoint
* Strong written and oral communication skills
* Detail-oriented and highly organized
* Ability to work independently
* Excellent organizational skills and attention to detail
* Compliance with applicable regulatory requirements
Up to 5% travel may be required. Periodic travel to other Werfen sites.
If interested in a challenging and learning-oriented environment, please submit your resume or CV.
Werfen is an Equal Opportunity Employer committed to diversity. We prohibit unlawful discrimination, harassment, or retaliation based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, medical condition, marital status, veteran status, or any other protected characteristic. For accommodations during the application process, please contact us.
We operate in over 30 countries and have a global workforce of more than 7,000 employees, with annual revenue of approximately $2 billion.
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